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N/A Completed N=229 Randomized Double-blind Prevention

Cinnamon Trial-lIfestyle iNtervention Plus Water-soluble Cinnamon Extract On loweriNg Blood Glucose in Pre-diabetics

Diabetes · Pre-Diabetes
Source: ClinicalTrials.gov NCT01301521 ↗
Enrolled (actual)
229
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Water-soluble Cinnamon — 15; 11; 32; 32 Participants

Summary

The purpose of this study is to assess whether water-soluble cinnamon extract plus aggressive lifestyle intervention is effective in lowering blood glucose in pre-diabetic patients when compared to aggressive lifestyle therapy plus placebo.

Outcome Measures

OutcomeResultp-value
PRIMARY
Water-soluble Cinnamon
15; 11; 32; 32

Eligibility Criteria

THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.

Inclusion:

Patients will be MOFMC, WHASC, DGMC, Eglin, and Offutt DoD beneficiaries, ages 18-65 years.

Diagnosis of pre-diabetes (defined as a fasting plasma glucose (FPG) 100-125mg/dl, Hemoglobin A1c 5.7-6.4%, or a 2-hour oral glucose tolerance test (OGTT) 140-199).

Exclusion:

Patients who are less than 18 yrs of age or greater than 65 years of age.

Patients who are known to have or develop during the study any of the following upon review of their medical record:

  • Diabetes Mellitus (defined as fasting plasma glucose (FPG) greater than 126mg/dl, hemoglobin A1C greater than 6.5%, or a 2-hour oral glucose tolerance test (OGTT) greater than 200mg/dl)
  • Stage 3 kidney disease or worse
  • Renal insufficiency defined as a glomerular filtration rate (gfr) of less than 60ml
  • Celiac disease
  • Insulinoma
  • Cushing's disease
  • Hyperthyroidism
  • Acromegaly
  • Pheochromocytoma
  • Addison's disease
  • Galactosemia
  • Glycogen storage disease
  • Hereditary fructose intolerance

Patients taking any of the following:

  • Cinnamon as a dietary supplement
  • Daily oral steroids
  • Warfarin
  • Hypoglycemic medication
  • Weight loss medication
  • Digoxin, lithium, phenytoin, & theophylline (due to their narrow therapeutic indices) Patients who are pregnant or breast feeding Patients with a known allergy to cinnamon Patients with a known allergy to wheat
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01301521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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